Drug Approval | June 27, 2022
Astellas’s update on the Fortis clinical trial of AT845 in adults for pompe disease
The FDA informed Astellas that it did not have sufficient information to assess the risks to subjects
The FDA informed Astellas that it did not have sufficient information to assess the risks to subjects
Both vaccine candidates demonstrated a favorable safety and tolerability profile similar to the Pfizer-BioNTech COVID-19 Vaccine
ANI’s Clorazepate Dipotassium Tablets are the generic version of the Reference Listed Drug (RLD) Tranxene.
Intended for potential treatment of ER+/HER2- advanced or metastatic breast cancer patients
V116 designed to target serotypes that account for 85% of all invasive pneumococcal disease in individuals aged 65 and over in the United States as of 2019
The ground floor of the formulation development laboratory is focused on solid orals, the first floor on injections, and the second floor houses the analytical lab
Dr. Reddy's Sorafenib Tablets, USP, are available in 200 mg tablets in bottle count sizes of 120.
Alopecia areata usually presents as a few small bald patches in the head
First and only FDA-approved device of its kind demonstrates consistently high rates of target limb salvage and freedom from clinically-driven target lesion revascularization
Acceptance based on results from the phase 3 KEYNOTE-091 trial
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